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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Parkinson's Disease | Study protocol

Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial

Authors: Charity G. Patterson, Elizabeth Joslin, Alexandra B. Gil, Wendy Spigle, Todd Nemet, Lana Chahine, Cory L. Christiansen, Ed Melanson, Wendy M. Kohrt, Martina Mancini, Deborah Josbeno, Katherine Balfany, Garett Griffith, Mac Kenzie Dunlap, Guillaume Lamotte, Erin Suttman, Danielle Larson, Chantale Branson, Kathleen E. McKee, Li Goelz, Cynthia Poon, Barbara Tilley, Un Jung Kang, Malú Gámez Tansey, Nijee Luthra, Caroline M. Tanner, Jacob M. Haus, Giamila Fantuzzi, Nikolaus R. McFarland, Paulina Gonzalez-Latapi, Tatiana Foroud, Robert Motl, Michael A. Schwarzschild, Tanya Simuni, Kenneth Marek, Anna Naito, Codrin Lungu, Daniel M. Corcos, The SPARX3-PSG Investigators

Published in: Trials | Issue 1/2022

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Abstract

Background

To date, no medication has slowed the progression of Parkinson’s disease (PD). Preclinical, epidemiological, and experimental data on humans all support many benefits of endurance exercise among persons with PD. The key question is whether there is a definitive additional benefit of exercising at high intensity, in terms of slowing disease progression, beyond the well-documented benefit of endurance training on a treadmill for fitness, gait, and functional mobility. This study will determine the efficacy of high-intensity endurance exercise as first-line therapy for persons diagnosed with PD within 3 years, and untreated with symptomatic therapy at baseline.

Methods

This is a multicenter, randomized, evaluator-blinded study of endurance exercise training. The exercise intervention will be delivered by treadmill at 2 doses over 18 months: moderate intensity (4 days/week for 30 min per session at 60–65% maximum heart rate) and high intensity (4 days/week for 30 min per session at 80–85% maximum heart rate). We will randomize 370 participants and follow them at multiple time points for 24 months. The primary outcome is the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) motor score (Part III) with the primary analysis assessing the change in MDS-UPDRS motor score (Part III) over 12 months, or until initiation of symptomatic antiparkinsonian treatment if before 12 months. Secondary outcomes are striatal dopamine transporter binding, 6-min walk distance, number of daily steps, cognitive function, physical fitness, quality of life, time to initiate dopaminergic medication, circulating levels of C-reactive protein (CRP), and brain-derived neurotrophic factor (BDNF). Tertiary outcomes are walking stride length and turning velocity.

Discussion

SPARX3 is a Phase 3 clinical trial designed to determine the efficacy of high-intensity, endurance treadmill exercise to slow the progression of PD as measured by the MDS-UPDRS motor score. Establishing whether high-intensity endurance treadmill exercise can slow the progression of PD would mark a significant breakthrough in treating PD. It would have a meaningful impact on the quality of life of people with PD, their caregivers and public health.

Trial registration

ClinicalTrials.​govNCT04284436. Registered on February 25, 2020.
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Metadata
Title
Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial
Authors
Charity G. Patterson
Elizabeth Joslin
Alexandra B. Gil
Wendy Spigle
Todd Nemet
Lana Chahine
Cory L. Christiansen
Ed Melanson
Wendy M. Kohrt
Martina Mancini
Deborah Josbeno
Katherine Balfany
Garett Griffith
Mac Kenzie Dunlap
Guillaume Lamotte
Erin Suttman
Danielle Larson
Chantale Branson
Kathleen E. McKee
Li Goelz
Cynthia Poon
Barbara Tilley
Un Jung Kang
Malú Gámez Tansey
Nijee Luthra
Caroline M. Tanner
Jacob M. Haus
Giamila Fantuzzi
Nikolaus R. McFarland
Paulina Gonzalez-Latapi
Tatiana Foroud
Robert Motl
Michael A. Schwarzschild
Tanya Simuni
Kenneth Marek
Anna Naito
Codrin Lungu
Daniel M. Corcos
The SPARX3-PSG Investigators
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06703-0

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